TECHNOLOGY & INNOVATION A


side from shining a light on the complexity of drug development and increased efforts in drug repurposing and de novo drug development, the Covid-19


pandemic saw decentralised clinical trials (DCTs) brought to the forefront as a solution to social distancing roadblocks. Having scaled the walls and surmounted the hurdles, it is decentralised solutions and not DCTs that look to be the future of clinical trials. The rise of decentralisation can largely


be attributed to its necessity within circumstance. However, a post-Covid environment has allowed the field to reflect on the workings of DCTs and adopt the most feasible and promising features of the trial modality, says Maria Harrison, vice president of operational capabilities at contract research organisation (CRO) Parexel. Elements of DCTs are looking to be a silver


lining of the pandemic. Now, it is down to the field to continue evolving the definition of sites, develop more advanced technological solutions, and optimise the role of decentralisation in clinical trials.


Hybrid: the new normal Though DCTs gained momentum during the pandemic, the idea of decentralisation has been around for a long time. Moreover, the extent of its applicability in trials can be divided into three phases: pre-Covid, the Covid-19 pandemic, and post-Covid. Pre-Covid was marked by innovation,


namely pushing how far a trial could move away from a clinical site using different solutions, technologies, and site models, explains Harrison. For many years, the industry has fixated on DCTs, adds Scott Palmese, executive director of decentralised clinical trials at Worldwide Clinical Trials: “Every company was trying to figure out


how everything could be virtual, or could add technology, and it never really stuck. It was repeating the exact same conversations, and nobody really wanted to make the investment to progress in that space,” says Palmese. While prior evaluation of innovations such


as e-consent and Home Health facilitated the implementation pathway of decentralised


20 | Clinical Trial Supply Handbook


solutions during the pandemic, the challenges of supercharging to ‘full force’ on short notice became apparent during this time, Harrison adds. The industry is at a point today where


stakeholders and vendors are taking a step back to reevaluate which elements of decentralisation worked and which fell flat. According to Harrison, what has become


increasingly apparent is that DCTs do not exist. “What I’ve seen in this post-Covid environment, is that there is no such thing as decentralised clinical trials. Today’s clinical trials have many decentralised clinical trial solutions that perhaps we did not see during Covid.” The emphasis on decentralised clinical trials becoming fully decentralised or applying decentralisation to every study has become a non-starter, adds Palmese. The industry is shifting towards a new norm:


the hybrid model, where certain decentralised elements are incorporated into studies, but only when they make sense.


Challenges of decentralisation Patients are an important stakeholder, and the start of decentralisation is largely attributed to increasing patient engagement bringing clinical trials to patients, says Harrison. However, decentralisation places a heavy burden on sites, which are also significant stakeholders in clinical trials, that have subsequently voiced a negative post- pandemic response to decentralised solutions because of these burdens. Post-pandemic, there seems to be a reverse


trend for decentralisation, where some pharmaceutical companies are pushing back on some additional costs of decentralisation that were a necessity during Covid and sites are often not excited about an additional “technology bloat” in studies, says Palmese.


In H1 2022, the top therapy area for DCT adoption was metabolic disorders


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